14 results
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20ms
·
Sources: EU EUDAMED, US FDA
PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX
FDA 510(k)
FDA Unclassified
·Unknown
7450 RV2 MASK
FDA UDI
HANS RUDOLPH, INC.·00817136025421·7450 LARGE W/HG MGC MADAPT
BD ULTRA FINE¿ PEN NEEDLES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code FMI·December 31, 2019
CONVOY ADVANCED DELIVERY SHEATH KIT
FDA 510(k)
FDA Class 1
·Immunology
NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BD ULTRA FINE¿ PEN NEEDLES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code FMI·December 31, 2019
BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code FMI·December 17, 2019
BD ULTRA FINE¿ PEN NEEDLES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code FMI·January 8, 2020
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·August 7, 2013
RUSCH GREENSPEC FO BLADE, MILLER 3
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CAL·May 7, 2013
CONCERTO II CRT-D
FDA Adverse Event
Death
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·September 24, 2014
VASOVIEW HEMOPRO 2 EVH SYSTEM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·May 17, 2011
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025